It has been estimated that 6% of men and 18% of women in the United States currently suffer from migraine headaches. Often, patients experience 30 or more potentially debilitating attacks a year. Current treatments include a range of over-the-counter analgesics as well as ergotamines and triptans.
Recently, reports have indicated that combination therapies in which triptans are combined with NSAIDs greatly improve the relief available to migraine patients (U.S. Pat. No. 6,060,499; U.S. Pat. No. 5,872,145; see also U.S. Pat. No. 6,384,034; U.S. 2002/0099059; EP 1051993; EP 1064967; EP 1051995; EP 10649966; and EP 1064948). In general, NSAIDs have been delivered orally, for example in the form of either single or multilayer tablets or as coated granules (U.S. Pat. No. 6,365,184; U.S. Pat. No. 5,637,320; U.S. Pat. No. 5,480,650; and U.S. Pat. No. 6,387,410). Triptans have been given orally, intranasally and by injection (see, e.g., U.S. Pat. No. 4,816,470; U.S. Pat. No. 5,307,845; U.S. Pat. No. 5,307,953; U.S. Pat. No. 5,554,639; and U.S. Pat. No. 5,705,520; U.S. Pat. No. 6,368,627; and WO 00/06161).
Although a good deal of work has been done in the area of dosage forms for triptans and NSAIDs, relatively little is known about the properties of dosage forms. in which these agents are combined. The way in which such dosage forms are constructed may affect not only the stability of the individual therapeutic agents but also the speed at which the individual agents dissolve and become available to provide pain relief to patients.